The purpose of this study is to determine if surgery using a plate and screws to fix a forearm fracture (ulnar shaft) will improve functional outcome compared to non-operative treatment out to 1 year of follow-up. It is hypothesized that in skeletally mature patients with isolated ulnar shaft fractures, the patients treated with surgery will have improved functional outcomes compared to non-surgical treatment with below-elbow cast at 1-year follow-up. This will be measured by the Disabilities of the Arm, Shoulder and Hand (DASH) scores. Secondary outcomes will include SF-36, range of motion, pain, grip strength, return to work, and time to union.

An evaluation of the range of motion about the wrist and the elbow for both the affected limb and the unaffected limb post-treatment. It will be evaluated starting at 2 weeks for the surgical group and at 6 weeks for the below-elbow cast group.

Grip Strength [ Time Frame: 6 weeks, 12 weeks, 6 months, 1 year ]

An evaluation of the grip strength for both the affected limb and the unaffected limb post-treatment.

Isolated ulnar shaft fractures will be treated with open reduction and internal fixation using a limited contact dynamic compression (LC-DC) plate with screws. These will remain at the fracture site for the lifetime of the patient.

Procedure: Open reduction and internal fixation

Patients will undergo surgery for open reduction of the fracture and internal fixation with an LC-DC plate and screw fixation.

The aim of this study is to determine if open reduction and internal fixation (ORIF) is more efficacious than closed reduction and below-elbow casting for 6 weeks in restoring function of the forearm and wrist.

The primary objective is to compare Disabilities of the Arm, Shoulder and Hand (DASH) scores at 1-year post-injury. Secondary outcome measures include SF-36, range of motion, pain, grip strength, return to work and time to union.

The study design is a multi-centre, open-label parallel randomized clinical trial. 100 skeletally mature patients with closed, extra-articular isolated ulnar diaphyseal fractures will be randomized to one of the two treatment arms. Polytrauma patients or those with pre-existing bone pathology will be excluded. Post-treatment follow-up evaluation will occur at 2, 6 and 12 weeks and at 6 and 12 months. Interim analysis will be completed by an independent Data Safety and Monitoring Committee to ensure patient safety.

Radiologic displacement, angulation and time to union will be evaluated by two independent, blinded observers. Time to fracture union will be defined as bridging callus across the fracture line on 2 views.

The sample size was calculated as 50 patients per group. Independent samples t-test will be used to compare the DASH and SF-36 scores and return to work. An ANOVA will be used for the DASH, SF-36 and range of motion comparison at each follow-up.

There is true clinical equipoise regarding optimal treatment for isolated ulnar diaphyseal fractures, therefore, the results of this trial will provide robust evidence for clinical decision-making in the treatment of these injuries by orthopaedic surgeons.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Over 18 years of age and skeletally mature

Subject has an isolated extra-articular ulnar diaphyseal fracture

Subject presents within 14 days or less between injury and study recruitment

Patient must be medically fit for anesthesia

Subject is willing and able to provide written informed consent for trial participation

Subject is willing and able to comply with the study protocol including return for all follow-up evaluations

Subject has a delay in treatment greater than 14 days from time of injury

Subject has an active infection in the area of surgical approach

Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong ulnar fracture healing time (another long bone fracture, ipsilateral limb injury)

Subject has a history of rheumatoid arthritis, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis

Subject has a high risk of death from surgery (ASA physical status Class V)

Subject is likely unable to maintain follow-up (no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc)

Subject has cognitive impairment or language difficulties that would impeded the valid completion of questionnaires

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01123447